SHARED CARE AGREEMENT. between. Alder Hey Children's NHSFT and Liverpool CCG

Transcription

1 This policy statement is approved by Liverpool CCG Halton Liverpool St Helens Warrington West Lancashire SHARED CARE AGREEMENT between Alder Hey Children's NHSFT and Liverpool CCG Methylphenidate (Ritalin, Equasym, Concerta XL, Medikinet ) and Atomoxetine (Strattera ) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) In Children Over 6 Years and Adolescents Date Prepared: January 2013 Date for Review: April 2016 INTRODUCTION The aim of this Shared Care Guidance is to ensure that GPs have sufficient information about this medication to enable them to undertake maintenance prescribing and clinical responsibility in conjunction with specialist colleagues. This guidance is not intended to be prescriptive and may be amended according to the individual clinician s views and patient circumstances. The agreement to shared care is voluntary and dependant on individual practitioner s knowledge, understanding, ability and willingness to accept clinical responsibility and associated prescribing for their patient. INDICATION FOR SHARED CARE ADHD is defined by the core symptoms of inattention, hyperactivity and impulsiveness. Some of these symptoms may be more dominant than others. Symptoms are present in multiple settings (for example, the home, school or healthcare setting) and in multiple social or personal functions (for example, achievement in schoolwork, forming positive relationships). People with severe ADHD often have low self-esteem, develop emotional and social problems and frequently underachieve. Current treatments for ADHD include a range of social, psychological, pharmacological and dietary interventions. ADHD is considered to be a developmental disorder resulting from immaturity of Prepared: Jan 2013 Page 1 of 15

2 brain inhibitory systems. Methylphenidate and atomoxetine are licensed in children 6 years or older as part of a comprehensive treatment programme for ADHD, under specialist supervision, where remedial measures alone prove insufficient. The National Institute for Health and Clinical Excellence (NICE) issued a clinical guideline, Attention Deficit Hyperactivity Disorder (number 72) in September 2008 and a Technology Appraisal (number 98) on the drugs used to treat ADHD in March Both of these documents advise that treatment for ADHD should only be initiated by a healthcare professional with expertise in ADHD and should be based on a comprehensive assessment and diagnosis. It is recognised in both of these documents that continued prescribing and monitoring of drug therapy can be performed in primary care, under locally agreed shared care arrangements. CRITERIA FOR SHARED CARE Children aged 6 years or older with ADHD who have been assessed by a specialist in ADHD management and in whom: It is agreed by the specialist and the patient s GP that the patient s condition is stable and predictable Multi-disciplinary support including education and social components have been established before transfer of prescribing to the GP Both the specialist and the GP agree to the shared care arrangement (in accordance with Responsibilities of General Practitioners) and a signed copies of the shared care agreement (appendix 1&2) have been returned by the patient s GP to the specialist DRUGS TO BE COVERED, DOSAGE AND ADMINISTRATION Methylphenidate (see appendix 3) Atomoxetine (see appendix 4) ADVERSE EFFECTS Methylphenidate (see appendix 3) Atomoxetine (see appendix 4) DRUG INTERACTIONS Methylphenidate (see appendix 3) Atomoxetine (see appendix 4) PATIENT INFORMATION See appendix 5 ADDITIONAL INFORMATION The following additional information should be provided by the consultant Growth chart Paediatric BP and HR chart SUPPORT & ADVICE Dr. Ruwan DeSoysa Telephone ext 3068 Prepared: Jan 2013 Page 2 of 15

3 Monitoring Baseline measurements are to be carried out by specialist. Thereafter GP is to monitor at 3 monthly intervals, except where this coincides with annual assessment by specialist at which time specialist undertakes this. Regular monitoring requirements for methylphenidate and atomoxetine are as follows: Height Baseline then every 6 months where still appropriate, unless indicated otherwise by the specialist Weight Baseline, at 3 and 6 months, then every 6 months, unless indicated otherwise by the specialist Height & weight should be plotted on a growth chart Blood pressure & heart rate Baseline then every 3 months and before and after each dose change BP and heart rate should be plotted on a centile chart FBC (for methylphenidate) Periodic FBC is recommended by the manufacturers for patients on long-term therapy. Undertake an immediate full blood count if the patient has prolonged or severe infection in order to exclude a blood dyscrasia Prepared: Jan 2013 Page 3 of 15

4 SHARED CARE ARRANGEMENTS AND COMMUNICATION CONSULTANT AND CLINICS RESPONSIBILITY Responsibilities relevant to all shared care requests: 1) Initial diagnosis, assessment, treatment initiation and stabilisation (minimum 1 month) and advice to patient. Confirm that there are no contra-indications to treatment. 2) To carry out a pre-treatment assessment to include: Full mental health and social assessment Assessment of medical and family history Baseline monitoring of height, weight, BP, heart rate, blood parameters, ECG and neurological examination, where appropriate Risk assessment for drug misuse or diversion 3) To inform the GP that methylphenidate/atomoxetine therapy has commenced and write to formally request shared care, including a copy of this guidance and shared care agreement form with the letter It is imperative that it is a consultant that signs the request for shared care. 4) Additionally the following information is required: diagnosis of patient s condition with relevant clinical details details of patient s treatment to date frequency of review by consultant 5) To inform patient of the dosage of medication to be taken. 6) Continue to prescribe and monitor the medication until patient is safely established on a stable dose and until the patient s GP has commenced prescribing and monitoring 7) Assess the patient regularly (at least every 12 months) or as necessary for the duration of therapy. Review patients promptly if required by the GP concerned. 8) Report any adverse effects of treatment GENERAL PRACTITIONERS RESPONSIBILITY Responsibilities relevant to all shared care requests: 1) Reply to consultant s written request to shared care within 14 days ensuring both copies of the Shared Care Agreement (Appendix 1 & 2) are signed. 2) Notify theconsultant of any circumstances that may preclude the use of methylphenidate, e.g. the use of illicit drugs or contra-indications to treatment. 3) Ensure consultant has provided the appropriate information regarding the therapeutic issues relating to the patient s clinical condition. 4) Prescribe methylphenidate / atomoxetine therapy at the dose advised by the consultant, specifying dose on the prescription and ensuring monitoring is up to date and results satisfactory each time a prescription is issued. Under Controlled Drug Regulations prescriptions for methylphenidate should be for 30 days of treatment at a time. 5) Carry out on-going monitoring as specified in Monitoring section above and if abnormality occurs, contact consultant or specialist nurse for advice when necessary. 6) For methylphenidate undertake immediate full blood count if the patient has prolonged or sever infection in order to exclude a blood dyscrasia. Copy all results to the consultant or specialist nurse. 7) Monitor patient s general wellbeing on a regular basis (at least every 6 months). 8) Report any adverse effects of treatment to the consultant and report to the MHRA using the Yellow Card system at the back of the BNF or report online at Prepared: Jan 2013 Page 4 of 15

5 to the MHRA using the Yellow Card system at the back of the BNF or report online at 9) Inform the consultant of any relevant change in the patient s circumstances. 10) Report any unexpected or inappropriate requests for medication to the consultant or nurse specialist 11) It is recommended READ code 6652 Shared Care-specialist/GP is entered onto patient record to highlight existence of shared care for the patient TAKING BACK PRESCRIBING RESPONSIBILITY If at any time the GP feels it to be in the best interest of the patient for prescribing responsibility to transfer back to the Consultant the Consultant will accept such a transfer within a timeframe appropriate to the clinical circumstances. References The National Institute for Health and Clinical Excellence (NICE) issued a clinical guideline, Attention Deficit Hyperactivity Disorder (number 72) in September Technology Appraisal 98 Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) in children and adolescents (review) Prepared: Jan 2013 Page 5 of 15

6 HOSPITAL COPY Appendix 1: Shared Care Agreement For the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children over 6 years and adolescents Request by..consultant for GP to enter into a shared care agreement for [name of drug] prescription Part 1 - to be signed by Consultant Date Name of patient Address Patient NHS No If using addressograph label please attach one to each copy Patient hospital unit No Diagnosed condition Dear Dr I request that you prescribe (1) (2) (3) for the above patient in accordance with the enclosed shared care protocol. The next monitoring blood test is due followed by blood test every weeks/months. Full details are contained in the attached letter. Name Date Designation Consultant Signature Part 2 to be completed by GP I *agree/do not agree to prescribe for the above patient in accordance with the enclosed shared care protocol *please delete as appropriate GP Date GP: Please sign both copies and return one copy within 14 days to: 1) Dept. [Insert contact details] Please retain the second copy for your clinical records. Thank you Prepared: Jan 2013 Page 6 of 15

7 GP COPY Appendix 2: Shared Care Agreement For the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children over 6 years and adolescents Request by..consultant for GP to enter into a shared care agreement for [name of drug] prescription Part 1 - to be signed by Consultant Date Name of patient Address Patient NHS No If using addressograph label please attach one to each copy Patient hospital unit No Diagnosed condition Dear Dr I request that you prescribe (1) (2) (3) for the above patient in accordance with the enclosed shared care protocol. The next monitoring blood test is due followed by blood test every weeks/months. Full details are contained in the attached letter. Name Date Designation Consultant Signature Part 2 to be completed by GP I *agree/do not agree to prescribe for the above patient in accordance with the enclosed shared care protocol *please delete as appropriate GP Date GP: Please sign both copies and return one copy within 14 days to: 1). Dept. [Insert contact details] Please retain the second copy for your clinical records. Thank you Prepared: Jan 2013 Page 7 of 15

8 Appendix 3: Methylphenidate Information Sheet Usual initiation and maintenance dose Equivalent doses Modified release preparations of methylphenidate should be prescribed by brand name, as the different preparations are not interchangeable Formulations and strengths available Contra-indications Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Standard Release 5mg one to two times daily, increased if needed at weekly intervals by 5 10mg daily to suitable maintenance dose. Maximum recommended dosage 60mg daily in 2 3 divided doses but may be increased to 2.1mg/kg daily in 2 3 divided doses up to a maximum of 90mg. Discontinue if no response after 1 month Prolonged Release: Concerta XL, Equasym XL, Medikinet XL equivalent to doses of standard release as above Concerta XL compared to standard release 18mg od Concerta XL = 5mg tds of standard 36mg od = 10mg tds 54mg od = 15mg tds Equasym XL compared to standard release 10mg od Equasym XL = 5mg bd of standard 20mg od = 10mg bd 30mg od = 10mg tds 60mg od = 20mg tds Medikinet XL compared to standard release 10mg od of Medikinet XL = 5mg bd of standard 20mg od = 10mg bd 30mg od = 10mg tds Methylphenidate hydrochloride tablets 5mg, 10mg and 20mg, in packs of 30 tablets Ritalin 10mg scored tablets, in packs of 30 tablets Concerta XL modified release 18mg, 27mg and 36mg tablets, in packs of 30 tablets Equasym XL modified release 10mg, 20mg and 30mg tablets, in packs of 30 tablets Medikinet XL modified release 5mg, 10mg, 20mg, 30mg and 40mg capsules, in packs of 30 capsules Modified release preparations should be swallowed whole, not chewed Anxiety or agitation, tics, tics in siblings or a family history of Tourette s syndrome or other movement disorder, hyperthyroidism, thyrotoxicosis, severe angina, severe hypertension, cardiac arrhythmias, heart failure, myocardial infarction, other cardiovascular disease, glaucoma, pregnancy, breast-feeding, known drug dependence or history of drug dependence or alcoholism, severe depression, schizophrenic symptoms, psychosis, anorexia nervosa, psychopathological personality structure, history of aggression, suicidal tendency, hypersensitivity to methylphenidate or other components of the product Prepared: Jan 2013 Page 8 of 15

9 Drug interactions Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Prescription requirements Coumarin anticoagulants e.g. warfarin Methylphenidate inhibits metabolism of coumarin anticoagulants leading to an increased anticoagulant effect Antidepressants Methylphenidate may inhibit the metabolism of SSRIs and tricyclics, leading to increased plasma levels. Risk of hypertensive crisis with MAOIsshould not be used within 14 days of taking an MAOI Phenylbutazone methylphenidate may inhibit the metaboliam of phenybutazone Anticonvulsants Methylphenidate inhibits the metabolism of phenytoin, primidone and phenobarbital, leading to increased plasma levels Clonidine serious adverse effects reported when used concomitantly with methylphenidate. Safety of using methylphenidate in combination with methyldopa and moxonidine has not been evaluated Volatile liquid general anesthetics increased risk of hypertension Adrenergic neurone blockers i.e. guanethidine Methylphenidate antagonises the hypotensive effect of adrenergic neurone blockers Antipsychotics haloperidol and thioridazine Alcohol may exacerbate the CNS adverse effects of methylphenidate. It is advisable for patients to abstain from alcohol during treatment Other sympathomimetics, incl those found in some cough and cold remedies hypertensive effect may be augmented. Advice should be sought from a pharmacist before buying medicines Methylphenidate is a schedule 2 controlled drug. The prescription must state: Name and address of the patient Drug name Drug form i.e. tablets Drug strength Dose as directed is not acceptable Quantity in words and figures Date Prescribers signature The validity of prescriptions for schedule 2 controlled drugs is 28 days from the date stated on prescription It is best practice under Controlled Drug Regulations to issue a maximum of 30 days of treatment at a time This information does NOT replace the manufacturer s SPC, which should be read in conjunction with this guidance Prepared: Jan 2013 Page 9 of 15

10 Appendix 4: Atomoxetine Information Sheet Usual initiation and maintenance dose Formulations and strengths available Body weight under 70kg initially 500 micrograms/kg daily for 7 days then increased according to response to usual maintenance dose 1.2mg/kg daily Body weight over 70kg initially 40mg daily for 7 days then increased according to response to usual maintenance dose 80mg daily. Maximum 100mg daily Total daily dose may be given either as a single dose in the morning or in 2 divided doses with last dose no later than early evening Strattera 10mg, 18mg, 25mg 40mg and 60mg in packs of 7 and 28 capsules Contra-indications Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Cautions Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Hypersensitivity to atomoxetine or any of the excipients, glaucoma, breast-feeding Cardiovascular or cerebrovascular disease including hypertension and tachycardia; history of seizures; patients with congenital or acquired long QT interval or a family history of QT prolongation;psychotic or mania symptoms; known serious structural abnormalities (in these cases atomoxetine should only be prescribed in consultation with a cardiac specialist), hepatic insufficiency, poor metabolisers of CYP2D6 enzymes Atomoxetine should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus, as there is a lack of clinical data CSM Advice Following rare reports of hepatic disorders, children and carers should be advised of the risk and be told how to recognised symptoms; prompt medical attention should be sought in case of abdominal pain, unexplained nausea, malaise, darkening of the urine or jaundice Following reports of suicidal thoughts and behaviour, patients and their carers should be informed about the risk and told to report clinical worsening, suicidal thoughts or behaviour, irritability, agitation or depression Prepared: Jan 2013 Page 10 of 15

11 Adverse effects Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Drug interactions Refer to manufacturers Summary of Product Characteristics (SPC) for complete up-to-date list Report all adverse effects to the MHRA Very common ( 10%): decreased appetite headache, somnolence, abdominal pain, vomiting, nausea Common ( 1% to <10%): anorexia, decreased weight, irritability, mood swings, insomnia, dizziness, increased BP, constipation, dyspepsia, dermatitis, rash, fatigue, lethargy Uncommon ( 0.1% to <1%): suicide related events, aggression, hostility, emotional lability, early morning awakening, syncope, migraine, tremor, mydriasis, palpitations, sinus tachycardia, pruritus, hyperhidrosis, allergic reactions, asthenia Spontaneous reports (from clinical experience): Psychosis including hallucinations, agitation; seizure; QT prolongation, Raynauds syndrome, abnormal LFTs, hepatitis, jaundice, urinary hesitation, urinary retention, priapism, male genital pain Omit dose and discuss with specialist if the following occur: Clinically significant increase in blood pressure, increase in seizure frequency, heart rhythm changes, blurred eyesight Avoid concomitant administration of drugs that prolong the QT interval (neuroleptics, class IA and III anti-arrhythmics, moxifloxacin, erythromycin, methadone, mefloquine, tricyclic antidepressants, lithium, or cisapride) Analgesics increased risk of ventricular arrhythmias with methadone; possible increased risk of convulsions with tramadol Anti arrhythmics increased risk of ventricular arrhythmias with amiodarone, disopyramide or procainamide Antibacterials increased risk of ventricular arrhythmias with parental erythromycin; increased risk of ventricular arrhythmias with moxifloxacin Antidepressants Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs). Atomoxetine should not be used within a minimum of 2 weeks after discontinuing therapy with MAOI. Treatment with MAOI should not be initiated within 2 weeks after discontinuing atomoxetine; possible increased risk of convulsions; increased risk of ventricular arrhythmias with tricyclics; metabolism possibly inhibited by fluoxetine and paroxetine; additive effects with imipramine, venlafaxine and mirtazepine Antimalarials increased risk of ventricular arrhythmias and convulsions with mefloquine Antipsychotics increased risk of ventricular Prepared: Jan 2013 Page 11 of 15

12 arrhythmias with antipsychotics that prolong the QT interval; increased risk of convulsions Beta blockers increased risk of ventricular arrhythmias with sotalol Bupropion possible increased risk of convulsions Decongestants additive effects with pseudoephedrine or phenylephrine Diuretics risk of ventricular arrhythmias increased by hypokalaemia caused by diuretics Sympathomimetics increased risk of cardiovascular side effects with parental, high-nebulised or oral salbutamol Other drugs that increase blood pressure (pressor agents) atomoxetine may increase BP, so should be used cautiously with other drugs that also exert this effect This information does NOT replace the manufacturer s SPC, which should be read in conjunction with this guidance Prepared: Jan 2013 Page 12 of 15

13 Appendix 5: Patient Information Leaflet What is Attention Deficit Hyperactivity Disorder (ADHD)? Attention Deficit Hyperactivity Disorder (ADHD) is the most common behavioural disorder in the UK. It is used to describe children who have: overactive behaviour (hyperactivity) and impulsive behaviour difficulty in paying attention Children with ADHD often find it difficult to fit in at school because they are overactive and impulsive. These difficulties can continue as they grow up, particularly if they and their families do not get the help they need. It is estimated that ADHD affects between 2-9% of school-age children and young people and approximately 2-4% of adults. ADHD is more commonly diagnosed in boys than in girls. Girls more commonly have symptoms of inattention while boys more commonly have symptoms of hyperactivity. What are the symptoms of ADHD? ADHD is a type of behaviour that is at the extreme end of normal. ADHD is diagnosed if a number of these characteristics are above the normal level. The main symptoms are: short attention span, inattention, difficulty concentrating, easily distracted, restless, e.g. constantly changing activity, not able to stick at one task hyperactivity - overactive, high activity levels, e.g. fidgeting, unable to sit still impulsive behaviour, suddenly doing things without thinking, little sense of danger, e.g. unable to wait for their turn, breaking set rules learning problems due to lack of attention, language and speech problems, although ADHD is not related to intelligence, and delayed social skills, difficulty making friends, problems with discipline This behaviour is usually first noticed at approximately five years old, with the behaviour occurring at home, at school and in other settings. What causes ADHD? The cause of ADHD is not certain. Genetic factors play a significant part. It tends to run in families. Research suggests that part of the brain works more slowly in children with ADHD, with changes in the parts of the brain that control activity and concentration. Children with ADHD may have an imbalance in the chemicals that carry messages in the brain. Parenting technique, family stress and too much sugar are not seen as a cause. Families with a child with ADHD may be stressed or disorganised, but this may be to do with the problems of coping with a child with ADHD. In a small number of cases, the cause it is thought to be due to injury to the brain during development e.g. premature birth (low birth weight) smoking, alcohol or drug abuse during pregnancy, having an accident or surgery during the first month of life. Having an hearing problem may also increase the risk of developing ADHD. Prepared: Jan 2013 Page 13 of 15

14 How does medication work? It is not completely clear how medication works in ADHD but it is thought that it stimulates a part of the child s brain that changes mental and behavioural reactions. It appears to affect a part of the brain, which allows us to control how we pay attention to what is going on around us. Medication is used in children and adolescents as part of a treatment programme, which would also include psychological, educational and social support. Treatment There is no cure for ADHD but treatment can reduce symptoms and make the condition less of a problem in day-to-day life. Is medication safe to take? Medication is safe to take, but it doesn t always suit everyone. You should let your doctor know if any of the following apply as extra care may be required: History of anxiety or depression History of heart or thyroid problems Taking other medications, including any medicines that are not prescribed History of tics (involuntary muscular contractions usually in the face, neck or shoulders) or a family history of Tourettes syndrome (multiple tics and involuntary speech) History of glaucoma (an eye disease) How long will my child need to take medication for? The length of treatment depends on how the person responds to the medicine. It would normally be stopped after one month if there was no sign of improvement but it may need to be continued for some years when it is of benefit. When the person has shown an improvement and the condition appears stable, the specialist may suggest a break from treatment, for example over a weekend or during school holidays. This helps to assess the need to continue with the medicine. Some children will be able to stop completely as teenagers, and some may be able to stop sooner. Others may have to continue as adults. How do I give the medication? It is important that your child takes their medicine at the same time each day as specified by your doctor. It is best to give these medicines after a meal or snack to prevent any nausea or loss of appetite. Doses are given at breakfast and lunchtime to provide control of behaviour during the daytime. A night time dose is sometimes given if the specialist decides that this would help. If your child experiences deterioration in concentration or behaviour in the late afternoon or evening, the specialist may suggest changing the times that the tablets are taken. The specialist may suggest a gradual increase of the dose over a few weeks until they see a satisfactory response and to keep side effects to a minimum. Atomoxetine is given once or twice a day. Prepared: Jan 2013 Page 14 of 15

15 What are the side effects of medication? Two common side effects are nausea and loss of appetite, particularly at the beginning of treatment. These can be helped and avoided by taking the medicines with a meal or snack. Sleeplessness can occur often at the beginning of treatment and the specialist may suggest that you alter the afternoon dose or add in an evening dose. The specialist or your GP may monitor the growth of your child, their blood pressure and may ask for blood tests during treatment to ensure that treatment is safe for your child. The risk of dependency i.e. addiction or need for a higher dose to get the same effect is often a concern for carers of children with ADHD. To keep this risk to an absolute minimum the specialist will use the lowest possible dose and may recommend occasional breaks in treatment. It is therefore very important that you do not alter the dose that your child has been prescribed. You should let your specialist or GP know as soon as possible if your child experiences any of the following: Persistent paleness or tiredness Persistent sore throat Unusual bruising or bleeding Unusual sores on the skin or in the mouth Blurred eye sight Heart beat faster than usual Low mood What should I do if I give too much? If your child accidentally takes too much medication, you should contact your doctor or NHS direct ( ) for advice immediately. Where can I get further help and information? If you have any other questions about your child s treatment, you should speak to your specialist, GP, pharmacist or NHS Direct ( ). Information adapted from NHS Direct Online Health Encyclopaedia (Attention Deficit Hyperactivity Disorder) and Newcastle, North Tyneside and Northumberland Mental Health NHS Trust Methylphenidate Information Leaflet. Prepared: Jan 2013 Page 15 of 15